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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018965
Receipt No. R000010770
Scientific Title Research for standardization of operative method of free jejunum transfer
Date of disclosure of the study information 2015/09/10
Last modified on 2017/03/14

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Basic information
Public title Research for standardization of operative method of free jejunum transfer
Acronym Research for standardization of free jejunum transfer
Scientific Title Research for standardization of operative method of free jejunum transfer
Scientific Title:Acronym Research for standardization of free jejunum transfer
Region
Japan

Condition
Condition Hypopharyngeal cancer, Cervical esophageal cancer
Classification by specialty
Oto-rhino-laryngology Plastic surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the influence of cranio-caudaly tensed free jejunum transfer for postoperative swallowing function in patients with total pharyngo-laryngo-cervical-esophagectomy.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes 6 month non-swallowing dysfunction rate
Key secondary outcomes postoperative complication rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Free jejunum transfer with cranio-caudaly tensile strength
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Ptients with hypopharyngeal cancer or cervical esophageal cancer
2)Patients undergoing total pharyngolaryngo cervical esophagotomy
3)Patients with Squamouse Cell Carcinoma
4)Patients without distant metastasis
5)Patients that an operation under the general anesthesia is possible
6)Patients with age 20 or more
7)Patients with performance status of 0,1
8)Patients who have submitted written informed consent
Key exclusion criteria 1)Patients with a history of esophagectomy or gastrectomy
2)Patients with excessive resection beyond the superior margin of tonsile
3)Ptients with resection of thoracic esophagus
4)Ptients with active cancer
5)Patients with severe or complicated medical conditions
6)Patients with psychiatric diseases
7)Patients who are not able to have written informed consent
8)Patients considered as inappropriate by their doctors
Target sample size 135

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Minoru Sakuraba
Organization National Cancer Center Hospital East
Division name Department of Plastic and Reconstructive Surgery
Zip code
Address 6-5-1Kashiwanoha, Kashiwa, Chiba, 277-8577, JAPAN
TEL 04-7133-1111
Email msakurab@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takuya Higashino
Organization National Cancer Center Hospital East
Division name Department of Plastic and Reconstructive Surgery
Zip code
Address 6-5-1Kashiwanoha, Kashiwa, Chiba, 277-8577, JAPAN
TEL 04-7133-1111
Homepage URL
Email takhigas@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East, Department of Plastic and Reconstructive Surgery
Institute
Department

Funding Source
Organization National Cancer Center Research and Development Fund23-A-26
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 1.国立がん研究センター東病院(千葉県)National Cancer Center Hospital East, Chiba
2.国立がん研究センター中央病院(東京都)National Cancer Center Hospital East,Tokyo
3.九州大学(福岡県)Kyushu University, Fukuoka
4.東京医科歯科大学(東京簿)Tokyo Medical and Dental University, Tokyo
5.東京大学(東京都)Graduate Schill of Medicine, University of Tokyo, Tokyo
6.岡山大学(岡山県)Graduate Schill of Medicine, Okayama University, Okayama
7.神戸大学(兵庫県)Graduate Schill of Medicine, Kobe University, Hyogo
8.愛知県がんセンター(愛知県)Aichi Cancer Center, Aichi
9.杏林大学(東京都)Kyorin University School of Medicien, Tokyo
10.東京慈恵医大(東京都)Jikei University School of Medicien, Tokyo
11.宮城県がんセンター(宮城県)Miyagi Cancer Center, Miyagi 

Other administrative information
Date of disclosure of the study information
2015 Year 09 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2012 Year 04 Month 18 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 13 Day
Last follow-up date
2016 Year 08 Month 12 Day
Date of closure to data entry
2016 Year 08 Month 13 Day
Date trial data considered complete
2016 Year 08 Month 13 Day
Date analysis concluded
2017 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 09 Month 10 Day
Last modified on
2017 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010770

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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